Statins do not commonly cause muscle pain: Lancet

In more than 90 per cent of cases, statin therapy is not likely to be the cause of muscle pain in a person taking statins, according to the most comprehensive analysis of the risks to date, published in The Lancet.
Statin therapy is widely prescribed as an effective prevention of cardiovascular disease but there have been widespread concerns that statins may frequently cause muscle pain or weakness.
The new study looks at individual patient data to provide a more detailed analysis of the risk of muscle pain caused statins than has previously been possible and concludes that this is low and does not outweigh the benefits of statin therapy.
“The idea that statins may cause frequent muscle pain has been a persent belief among some patients and clinicians, but our study confirms that the statin is rarely the cause of muscle pain in those taking statins,” says Professor Colin Baigent, director of the Medical Research Council Population Health Research Unit at the University of Oxford, and joint lead author of the study.
“These findings suggest that if a patient on statins reports muscle pain, then it should first be assumed that the symptoms are not due to the statin and are most likely due to other causes. Statin therapy should continue until other potential causes have been explored. Additionally, in light of our analysis, we believe there is a need to revise the information in the medication label for statins to clarify that most muscle pain experienced during statin therapy is not due to the statins.”
The authors told The Indian Express that statin therapies are affordable and widely available. “They are a key tool in helping prevent avoidable disability and death. An estimated 173 million people use a lipid modifying agent (statin or fibrate) daily in 2018 in 83 countries, according to an analysis published in 2021,” Baigent told The Indian Express, adding that the number is likely to be much higher worldwide.
The authors analysed data from 155,000 patients from 23 trials of statin therapy — each trial had over 1,000 patients and a follow-up time of over two years and had a double-blind comparison of statin vs placebo, or of a more or less intensive statin regimen. The authors compared rates of muscle symptoms in the group undergoing statin treatment with the placebo group to calculate the proportion of symptoms directly caused the statin therapy.
The meta-analysis found that, among 19 placebo-controlled trials with an average follow up period of four years, 27.1 per cent of patients who were given statins (16,835/62,028) reported muscle pain or weakness, compared to 26.6 per cent of those who were given the placebo (16,446/61,912). During the first year of treatment, statin therapy produced a 7 per cent relative increase in muscle pain or weakness compared to placebo, suggesting that only one in 15 of these muscle-related reports patients given statins were due to the statin. The absolute excess risk of muscle symptoms due to a statin was 11 per 1,000 patients treated in the first year. After the first year of treatment, there was no significant difference in reports of muscle pain or weakness between those given statins and those given the placebo.
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The researchers also looked at four randomised double-blind trials of more intensive versus less intensive statin therapy. The data from these trials was analysed alongside the placebo trials to see if the dose of statin made a difference to the risk of muscle pain caused the statin. The study did not find any clear evidence of a dose-response relationship, but it did find that in the first year of treatment, higher intensity statins caused a greater increase in the risk of muscle pain compared to placebo (an 11 per cent increase in risk) than moderate-intensity statin treatment compared to placebo (a 6 per cent increase in risk). They also found that after one year, the high intensity statin treatments produced a 5 per cent relative increase in muscle pain or weakness compared to placebo. This suggests that not only do high-intensity statin treatments lead to larger risks of muscle symptoms in the first year than moderate-intensity statins, but that there may be a persing low risk of such symptoms beyond this time.
The analysis also found that the small proportion of patients who did experience muscle symptoms caused statins did not usually stop their statin treatment.